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Clinical Trials/NL-OMON52660
NL-OMON52660RecruitingNot Applicable

Clinical trial to evaluate safety and efficacy of the C2 CryoBalloon 180° Ablation System for the treatment of dysplastic Barrett*s esophagus: CBAS180 de-escalation study - CBAS180 de-escalation study

Pentax Medical0 sites122 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
122

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • 1) Flat type BE esophagus, with an indication for ablation therapy, defined as:
  • a) Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
  • b) Residual BE with any grade of dysplasia after endoscopic resection (by means
  • of EMR or ESD) to treat non-flat BE, >=6 weeks prior to enrolling the patient to
  • this study. The ER pathology should indicate endoscopic treatment (i.e. only
  • mucosal invasion or limited submucosal invasion (sm1), no lymphovascular
  • infiltration, free vertical resection margins and not poorly differentiated).
  • 2) Prague Classification Score of C<=3 and M>=1.
  • 3) Patients should be ablation-naïve, meaning they have not undergone any
  • previous endoscopic ablation therapy of the esophagus.
  • 4) Older than 18 years of age at time of consent.
  • 5) Fit for endoscopic therapy per institution*s standards.
  • 6) Provides written informed consent on the IRB-approved informed consent form.
  • 7) Willing and able to comply with follow-up requirements.

Exclusion Criteria

  • 1) Esophageal stenosis preventing advancement of a therapeutic endoscope.
  • 2) Any endoscopically visualized lesion such as ulcers, masses or nodules.
  • Neoplastic nodules must first be treated with ER >=6 weeks prior to planned
  • treatment under this protocol.
  • 3) Prior ER of >2cm in length and/or >50% of the esophageal lumen
  • circumference.
  • 4) History of locally advanced (>sm1) esophageal cancer.
  • 5) History of esophageal varices.
  • 6) Prior distal esophagectomy.
  • 7) Active esophagitis LA grade B or higher.
  • 8) Severe medical comorbidities precluding endoscopy.
  • 9) Uncontrolled coagulopathy.
  • 10) Pregnant or planning to become pregnant during period of study.

Investigators

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